Checklists
Contains 12 Audit Checklists with questions linked To These Regulations, Standards & Guidelines: All checklists are provided in hard copy and on a CD that immediately calculates an audit rating
| US FDA & ICH Q7A |
GMPs for Active Pharmaceutical Ingredients |
| US 21CFR 1301-1304 |
DEA Requirements for Controlled Drugs |
| IPEC |
GMPs for Bulk Pharmaceutical Excipients |
| US 21CFR 111 |
GMPs for Dietary Ingredients and Supplements |
| US 21CFR 211 |
GMPs for Finished Pharmaceuticals |
| US FDA Guidance |
Quality System Approach to Pharmaceutical GMP |
| European Union (EU) |
GMP for Medicinal Products |
| US 21CFR 820 |
Quality System Regulations for Medical Devices |
| ISO 13485:2003 |
Quality Management System For Medical Devices |
| US 21CFR 821.25 |
Medical Device Tracking |
| US 21CFR 803.17 |
Medical Device Reporting |
| US 21CFR 806.10 |
Corrections and Removals (recalls) |
| US 21CFR Part 11 |
Electronic Records and Electronic Signatures |
| ISO 9003:2004 |
Application of 9001:2000 To Computer Software |
| ISO 9001:2008 |
Quality Management Systems |
| ISO 17025:2005 |
Testing and Calibration Laboratories |
| ISO 19011:2002 |
Quality/Environmental System Auditing |
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What’s New in the 8th Edition
- FDA’s Quality System Guideline For Drug Manufacturers
- FDA’s 21 CFR Part 111 cGMP Dietary Ingredients and Supplements Regulation
- ISO 19011-2002 Guidelines For Quality and/or Environmental Management System Auditing
- ISO 13485-2003 For Medical Device Quality Management Systems
- ISO 17025-2005 General Requirements For The Competence of Testing and Calibration Laboratories
Advantages to Using Checklists
- FDA CONDONED!!! These checklists have been presented to FDA investigators with very positive results being obtained.
- An easy way to show them that a comprehensive audit program was in place.
- Standardizes audits and minimizes subjectivity amongst auditors
- Easy, objective and quantifiable results through use of a rating system
- Assures auditing for compliance to all applicable regulations and standards Enables auditors to trace questions to the requirements.
What You Get
Narrative: A comprehensive explanation of the basic steps for preparing, performing, concluding and following up audits. Different types of audits are
discussed, including the rationale and instructions for performing internal, contractor and supplier audits.
Rating System: A rating system within each checklist so that you can answer each question with a value A rating system that gives you an overall compliance value for the audit.
Software (compact disc): Contains all of the questions in Excel format which automatically tabulates rating results. Download the checklists onto your computer, and print either blank or completed checklists
12 Audit Checklists, for effective auditing of:
- Device Manufacturer/Developer
- Drug Manufacturer
- Nutritional Manufacturer
- Contract Device Manufacturer/Developer
- Contract Drug Manufacturer
- Contract Nutritional Manufacturer
- Contract Software Developer
- General Supplier
- Chemical Supplier (including API’s)
- Printed Material Supplier
- Electronic Component Supplier
- Simulated QSIT (FDA Approach) For Drug and Device Inspections
About the Author
Leonard Steinborn is an ISO certified lead auditor with over 35 years of experience in the medical device and pharmaceutical industries.
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